UREA UR8334

GUDID 05055273209600

This product is intended for the quantitative in vitro determination of Urea in serum, plasma or urine.

RANDOX LABORATORIES LIMITED

Urea IVD, reagent

• Primary Device ID: 05055273209600
• NIH Device Record Key: 280d93a6-f1c4-4cda-b72b-f9429b256cad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UREA
• Version Model Number: UR8334
• Catalog Number: UR8334
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273209600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923506

FDA Product Code

• CDQ: Urease And Glutamic Dehydrogenase, Urea Nitrogen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [UREA]

• 05055273209600: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206975: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206968: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206951: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206944: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206937: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206920: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206913: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206906: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206869: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273206852: This product is intended for the quantitative in vitro determination of Urea in serum, plasma or
• 05055273216172: UR220